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The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Citicoline eye drops (OMK1)

Placebo Comparator: hypromellose based ocular lubricant

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Glaucoma Open Angle, Pseudoexfoliation Glaucoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years.
Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
Patients over the age of 18 years

Exclusion Criteria:

Patients with contraindications to citicoline
Patients with IOP higher than 18 mmHg
Patients with other forms of glaucoma
Patients treated with other neuroprotective therapies
Women who are pregnant and/or breastfeeding
Pediatric or adolescent patients aged under 18 years

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citicoline eye drops (OMK1)

hypromellose based ocular lubricant

Arm Description

45 patients will be treated with active treatment (OMK1)

45 patients will be treated with placebo (lubricant eye drops)

Outcomes

Primary Outcome Measures

Change in glaucomatous damage

The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.

Secondary Outcome Measures

progression of glaucoma in the SD OCT examination

assessment of the progression of glaucoma in the SD OCT examination (Retinal Nerve fiber Layer- RNFL evaluation) in the group that receives the topical citicoline together with ocular antihypertensive drug therapy compared to the group treated with the sole reduction of intraocular pressure. It will be used for the assessment of the progression of glaucoma the Brusini staging system.

Full Information

NCT ID

NCT04020705

First Posted

April 12, 2019

Last Updated

July 15, 2019

Sponsor

Istituto di Ricerca Neuroftalmologia S.r.l.

Collaborators

University of Milan

1. Study Identification

Unique Protocol Identification Number

NCT04020705

Brief Title

The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Official Title

The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 22, 2015 (Actual)

Primary Completion Date

March 19, 2019 (Actual)

Study Completion Date

March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto di Ricerca Neuroftalmologia S.r.l.

Collaborators

University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel. Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo. All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field). The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP). The secondary objective is to assess the tolerability and safety of OMK1 eye drops.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, Glaucoma Open Angle, Pseudoexfoliation Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Citicoline eye drops (OMK1)

Arm Type

Experimental

Arm Description

45 patients will be treated with active treatment (OMK1)

Arm Title

hypromellose based ocular lubricant

Arm Type

Placebo Comparator

Arm Description

45 patients will be treated with placebo (lubricant eye drops)

Intervention Type

Device

Intervention Name(s)

Citicoline eye drops (OMK1)

Intervention Description

(OMK1) will be prescribed in the dosage of 1 drop 3 times a day

Intervention Type

Other

Intervention Name(s)

Placebo Comparator: hypromellose based ocular lubricant

Intervention Description

will be prescribed in the dosage of 1 drop 3 times a day

Primary Outcome Measure Information:

Title

Change in glaucomatous damage

Description

Time Frame

Baseline and Visit at 36 months

Secondary Outcome Measure Information:

Title

progression of glaucoma in the SD OCT examination

Description

Time Frame

Baseline and Visit at 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis. Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years. Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study. Patients over the age of 18 years Exclusion Criteria: Patients with contraindications to citicoline Patients with IOP higher than 18 mmHg Patients with other forms of glaucoma Patients treated with other neuroprotective therapies Women who are pregnant and/or breastfeeding Pediatric or adolescent patients aged under 18 years

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

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